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PHARMA: The FDA can only be saved by new leadership, by Blunter

There’s a new contributor today on THCB. Blunter worked at the FDA for many, many years and understands from the inside many of the problems with the agency that have been documented in many places, such as this Forbes article. He responded to my notion that the problem is simply the speed of the drug approval process and suggests that the issues go way deeper. What he says about the management of the agency, the culture of secrecy and the information obfuscation is well worth taking seriously:

You and those following the travails of the Food and Drug Administration (FDA) are on the wrong track if your views of the FDA problems are focused on the rate of drug approvals and postmarketing reports. When it is finally revealed that gutless FDA executives sold User Fees as a solution (politically naive) instead of addressing the real management and public policy issues, the crux of the present problem is clarified. There is nothing inherently wicked about user fees but the original and subsequent managers didn’t press the other fundiing and management needs

Within a year of the first user fee enactment (about 12 years ago), FDA was meeting the new deadlines without hiring or training any new MD’s. And a whole reserve of physicians receiving premium pay and scientists are secreted away in the FDA halls in "non-traditional" endeavors—mainly management—often beyond their expertise and capabilities. Examples abound where FDA top execs are ignorant of basic management responsibilities and skills in themselves and their subordinates, beginning at the Commissioner’s Office.

Look at EPA, NASA, NHTSA (and its potential model NTSB) and compare basic budgets to that of FDA which regulates vastly more of the GDP. What regulatee would object to paying a few million dollars to get a statutory deadline and perhaps as little as an additional week or two of sales. Just divide $1 or $8 billion by 365 to see the daily return. And the user fee concept is spreading to devices, animal drugs, food, cosmetics.

FDA seeks an analysis and report by the National Academy of Science or other prestigious group as a CYA tactic. There are lots of similar reports lying around comatose from past misadventures. However, the tactic permits FDA and other Administration folks to say it is inappropriate to discuss specifics of the latest debacle(s) before receipt of the blue ribbon report. Hence, we have FDA on autopilot until the dust and fervor clears and a new executive crew gets in that can say that "it wasn’t on our watch".

This present controversy and period may end up as little more than a footnoted historic anecdote in the next report of the next FDA crises a few years hence. The answer involves leadership with a new and skilled management team, to make the FDA a safe and effective environment for FDA scientists (among the best) to do their best work, create a transparency in the work FDA does, and cause the Congress to accept responsibility for funding a mission that has no peer in the Federal government. For sure, more funding which would be effectively applied will be needed but unlikely to do much good so long as the current management and culture is allowed to continue.

Presently, outsiders who want or need information on FDA decisions, and the like, are channeled through a Freedom of Information process which takes two years or more just to get around to the request, and then some more time and redactions to get the info out, if indeed any is released. It has been a long-standing, recognized management incompetence, worse in the Center for Drug Regulation than anywhere else (probably in the whole government). There is no transparency in what FDA is acting on, or ability for any one to compare in real time other similar data by scientists or others, who may have data of their own or seek to learn from the existing records FDA has passed upon. And when it comes to other than medical and scientific data, the likelihood of getting anything at all to look at several years down the road is even more remote.

And there has been no effort in the last near decade to do anything about it, like introduce management or data submission processes to make the system workable. Human clinical data and drug experience (appropriately clad to protect patient privacy) is a public resource, not a trade secret, for example. But you’d never know it at FDA.

Ironically, the FDA cannot be suspended on life support while a solution is devised or changes made. But there is hope. Under Jimmy Carter, the prevailing view was the Presidency had grown too complex and demanding for one person, and the talk was how to divide it. Then came along Ronald Reagan, The Bushes, and Clinton, and those discussions are footnotes on history. What can an effective and motivated leader do? A lot. Still don’t believe that FDA’s lack of leadership isnn’t just an issue but the issue. Look at the Forbes Magazine story and survey (mentioned on one of your earlier blogs) and see that the need for leadership at FDA outranks the closest competitor by three times or more.

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